Pharmaceutical, Biotechnology & Diagnostic Industries

Edwards-Hunt Group excels at developing and implementing prospective, human biospecimen collection studies compliant with U.S. regulatory standards. 

Through our expansive, domestic network, we are able to offer timely collection of high quality, highly annotated biospecimens to support the drug/device development process.  

We offer contract research organization services :

• Principal Investigator
• Regulatory Package Development
• Remote & traditional study designs 
• Peripheral blood, urine, saliva, CSF, benign and malignant tissue, and fecal matter collections
• Racially and ethnically diverse population enrollment
• Site Identification - We specialize in rural community center identification & management.
• Contract & Budget Negotiation
• Site Management - Site Qualification through Study Closure Visit
• Site staff training - We specialize in "training up" the next generation of clinical research professionals.
• Daily Management of Clinical Studies
• Monitoring Services 
• Vendor Evaluation 

Edwards-Hunt Group combines experience and knowledge of the healthcare and drug/device development industries with business methodologies to develop solutions for our non-profit clients. We are uniquely positioned to understand our clients’ relationships with their constituents and business partners. Our background enables us to manage programs from concept to completion and navigate partner relations to meet and exceed your business objectives.  

We have successfully collaborated with non-profit organizations to achieve their translational medicine goals by providing a host of services. 

• Strategic Planning. Entering the  translational medicine arena is a complex endeavor, requiring an abundance of scientific and business resources to appropriately drive drug development in a particular disease group. Our staff collaborates with organizations to develop and institute plans up to five years out or less, depending upon the requirements of the organization.  
• Program Development. Our clients require novel programs to support their scientific and clinical efforts developed in a manner to support their fundraising activities. Our staff performs a gap analysis of the organizations’ programs providing a structured process to program generation, development and implementation. We specialize in managing programs from concept through implementation, providing a turn-key approach and minimizing the impact on limited internal resources. Our background enables us to develop operations and technology programs designed to support clinical research and biobanking programs. We do not employ a singular or pre-determined strategy across multiple clients; instead we recognize the individual needs and uniqueness of each disease group developing programs to support specific goals
• Technology and Human Resource Management. Identifying and implementing the appropriate technology and staff to support your efforts are critical in a time when fewer dollars are available. We are able to analyze our clients’ technology and human resource requirements providing recommendations and managing the vendor selection process, until our clients achieve the level of efficiency and expertise necessary to support their programs.